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CLEAFIL PHOTO BOND is indicated for the following applications:

• A dentin and enamel bonding system for composite resin restoration 1)
• 2. A dentin and enamel bonding system for amalgam restoration

CLEARFIL PHOTO BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.

The provided text is a 510(k) summary for a dental material (CLEARFIL PHOTO BOND) and a letter from the FDA. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them.

Specifically, the following points cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report performance data. It states the intent is to move the manufacturing to a subsidiary and that the new device is "essentially the same" as the predicate.
2. Sample size used for the test set and the data provenance: Not applicable, as no such test set or study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to inform the FDA that a previously cleared device (CLEARFIL PHOTO BOND by Kuraray Co., Ltd., K943165) will now be manufactured by a subsidiary (Kuraray Medical Inc.) with no changes to the device itself. The FDA letter confirms the substantial equivalence to the predicate device based on this information.

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